J&J Seeks FDA Approval for Nonsmall-Cell Lung Cancer Drug

Johnson & Johnson (J&J) is seeking FDA approval for its investigational drug amivantamab (JNJ-61186372) for patients with nonsmall-cell lung cancer (NSCLC) who suffer from a specific form of an epidermal growth-factor receptor (EGFR) mutation.

The filing is supported by interim data from a phase 1 trial evaluating the drug as a monotherapy and also combined with lazertinib, an EGFR tyrosine kinase inhibitor, in adults with late-stage forms of the disease.

Preliminary results for amivantamab alone showed an overall response rate of 36 percent in 39 patients, rising to 41 percent for the 29 participants who had previously undergone chemotherapy. The New Jersey-based drugmaker claims the drug’s safety profile was “manageable.”

J&J forged a potential $1.2 billion-plus agreement with South Korea’s Yuhan in 2018 for the development of lazertinib.

The FDA awarded amivantamab Breakthrough Therapy designation in March.